Safety and performance of trehalose hyaluronic acid versus standard infiltrative therapy based on medium weight sodium hyaluronate in knee joint osteoarthritis treatment

Efficacy evaluation of trehalose-hyaluronic acid versus non-trehalose hyaluronic acid in persistent symptomatic knee osteoarthritis patients, with outcome measurement comparison of KOOS, IKDC, and VAS score at basal, 3 and 6 months

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18428696

Enrollment

Registered

2021-09-30

Start date

2019-06-01

Completion date

Unknown

Last updated

2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

Participants are randomized with an allocation ratio of 1:1 to receive either T-HA or NT-HA. The manufacturer provided the products labelled as A or B (corresponding to group A or B, respectively). Bo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years 2. Symptomatic knee osteoarthritis, grade I to III according to Kellgren and Lawrence classification 3. Without pain relief after at least 3 months of non-invasive treatment 4. Osteoarthritis diagnosed by x-ray and classified according to Kellgren and Lawrence classification

Exclusion criteria

Exclusion criteria: 1. Any recent intra-articular injection therapy 2. Knee instability 3. Significant axial deviation 4. Systemic disorders such as rheumatoid arthritis, coagulopathies, or infections

Design outcomes

Primary

Measure	Time frame
Treatment performance measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), and Visual Analogue Scale (VAS) at baseline, 3, and 6 months	—

Secondary

Measure	Time frame
Safety measured using adverse reactions recorded for the duration of the trial	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026